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NCT03727997 Clinical Trial

Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

Acute Kidney Injury Clinical Trial

— InSEA-RRT  

Official title:
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03727997
Other study ID # InSEA-RRT Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date December 1, 2024

Study information
Verified date February 2024
Source Chulalongkorn University
Contact Nattachai Srisawat, MD
Phone 66818361891
Email drnattachai@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 1, 2024
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - AKI stage 3 - At least 18 years old Exclusion Criteria: - ESRD patients (eGFR < 15 mL/min/1.73 m2)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Faculty of Medicine, Chulalongkorn University Bangkok Pathumwan

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2-year mortality 2-year
Secondary Hospital mortality 28-day
Secondary RRT rate 28-day
Secondary Renal recovery Number of Participants with who survive. Number of Participants with dialysis independence and creatinine <1.5 mg/dL 28-day
Secondary 2-year major adverse kidney events Number of Participants with 25% or greater decline in eGFR. Number of participants who receive new renal replacement therapy (RRT). 2-year
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